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Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs Clinical research trials and Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs. Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs clinical trial. Participants oftentimes recieve the finest healthcare available for their Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs  Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
For Condition: HIV Infections,Pneumococcal Infections,Hepatitis B,Pertussis,Measles
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV) followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of children. This study will also look at the protection provided by childhood vaccination against measles, pertussis, and hepatitis B virus. Pneumococcal infections are the most common AIDS-related infection in HIV-infected children. PCV may help reduce the chances of HIV-infected children getting pneumococcal infections. This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected children receiving HAART. It will look at whether HIV-infected children are protected by childhood vaccines received previously and if more doses are safe and improve protection.
Details: Infection by Streptococcus pneumoniae is the most frequent opportunistic infection observed in HIV-infected children. PCVs are immunogenic and efficacious in normal children and offer hope of reducing pneumococcal infections in HIV-infected children. The degree to which children on HAART are protected by prior immunizations and are responsive to new immunizations is still largely undefined. This study is designed to answer whether PCV immunizations are safe and effective. The immune responses to prior immunizations and responsiveness to booster doses of vaccines against measles, pertussis, and hepatitis B virus of children on HAART will also be examined. Answers to these questions will determine whether these children are likely to be protected against these clinically relevant pathogens and whether they should routinely receive booster doses of these vaccines after a period of HAART. Patients are stratified on the basis of CD4 percentage and age. Patients that previously received a primary hepatitis B vaccine (HBV) series receive an HBV immunization at entry. Other vaccinations may be given (based on age and/or CD4 cell measurement, and immunization status) for PCV at entry and 2 months, and measles-mumps-rubella (MMR) vaccine and PPV at 4 months. Some patients may be administered DTaP at a 6-month visit on the basis of age, previous immunization history, and negative tetanus antibody status. Follow-up visits are done at 8, 12, and 24 months. Blood samples are collected at all clinic visits for assessment of HIV RNA, immune responses against pneumococcus, measles, pertussis, and hepatitis B virus, as well as for laboratory evaluations.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 2 Years/18 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are 2 to 18 years of age. - Are HIV-infected. - Have a viral load (amount of HIV in the blood) under 60,000 copies/ml within 30 days of study entry. - Have been on their current anti-HIV drugs for at least 3 months. - Have received 4 or more doses of a pertussis vaccine. - Have received 1 or more doses of measles vaccine unless a CD4 percent or CD4 number ruled out taking the vaccine. (This reflects a change in the CD4 requirement.) - Expect to be able to complete all study injections and follow-up. - Have a negative pregnancy test if able to have children and use effective methods of birth control. - Have parent or guardian's consent if under 18 years of age. - Have received an approved hepatitis B vaccine series. Not required for study entry, but children who have received this vaccine will be studied. - (This study was changed to allow patients who became HIV infected after birth, have a viral load between 30,000 and 60,000 copies/ml, and who have been on their current anti-HIV drugs for 3 to 6 months.) Exclusion Criteria Patients will not be eligible for this study if they: - Had a certain CD4 level before beginning anti-HIV drugs and at screening. - Have received any killed vaccine within 4 weeks, or any live vaccine within 6 weeks, of entering the study. - Have received pneumococcal vaccines or had a reaction to PPV. - Have had an allergic reaction to any measles or hepatitis B vaccines, or to other routine childhood immunizations if 13 years of age or less. - Have any other condition that would make receiving study vaccines inadvisable. - Are currently on medications that affect the immune system, except for G-CSF and erythropoietin. This includes the equivalent to more than 1 mg/kg/day of prednisone in the 2 weeks preceding study screening. Nonsteroidal anti-inflammatory agents and inhaled corticosteroids are not excluded. - Have received certain blood products within the previous 6 months. - Have other diseases of the immune system. - Have had cancer within 3 months of study screening or are being treated or have been treated for cancer within 3 months of study entry. - Are pregnant. - Have any other disease or previous surgery that would interfere with study treatment. - Are likely to have bleeding disorders. - Show certain side effects to vaccines at screening.
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
MarkAbzug, Study Chair,
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
The Med Ctr Inc
Columbus, Georgia, 31901
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
St Joseph's Hosp & Med Center
Paterson, New Jersey, 07503
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Univ of California, San Diego
San Diego, California, 92103
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Montefiore Medical / AECOM
Bronx, New York, 19461
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Univ of Florida Gainesville
Gainesville, Florida, 32610
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Harbor UCLA Med Ctr
Huntington Beach, California, 92646
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: ACTG P1024; PACTG 1024
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013871
Other Hepatitis B Studies:
1. Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
2. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
3. Intravenous Pertussis Immune Globulin in Patients with Severe Childhood Pertussis Infection
4. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
Related Studies:
Other Hepatitis B Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
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